Competitive RiskIntensifying competition and a trend toward combination approaches in MASH demand clear clinical differentiation, otherwise commercial uptake and market share could be limited.
Operational And Financial RiskClinical development setbacks, reimbursement and pricing challenges, capital market pressure or dilution, and potential trial disruptions from geopolitical or public health events could delay programs and negatively affect valuation.
Regulatory RiskFDA emphasis on biopsy-based endpoints and reluctance to fully accept non-invasive tests could require more burdensome trial designs and increase approval uncertainty.